Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met.
- Incorporating Excipients Into QbD Studies For Drug Development — An Introduction
- Cell and Gene Therapies Are Driving Investment Opportunities
- FDA Steps Up Support For Advanced Manufacturing Technologies
- Answer These 3 Questions Before Developing Software As A Medical Device
- FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers
- Philadelphia’s Talent Pipeline Collaborative Readies Region For Cell And Gene Therapy Job Growth
- Analytical Development Outsourcing At “Platform” Biopharma
Cell and Gene Therapies Are Driving Investment Opportunities
As technology advances in cell and gene therapy and investment continues in these technologies, life-changing and life-saving neurological therapies are an option available to anyone who needs it.
FDA Steps Up Support For Advanced Manufacturing Technologies
In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards. The MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.
Answer These 3 Questions Before Developing Software As A Medical Device
Whether your organization is interested in software adoption to build in continuous data acquisition, offer remote care capabilities, improve patient engagement, or simplify routine clinical tasks, software as a medical device (SaMD) is at the center of it. Before getting started on your SaMD project, answer these three questions.
FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers
Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.
Philadelphia’s Talent Pipeline Collaborative Readies Region For Cell And Gene Therapy Job Growth
On the heels of a 2020 study predicting substantial job growth in the cell and gene therapy sector in Greater Philadelphia, industry leaders in our region have created the Life Science Talent Pipeline Collaborative to ensure a strong talent pool for the future.
Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management
You’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.
The BPCIA And Declaratory Judgment: The Real Dance Partners?
In theory, the initial exchange process in the first phase of litigation is intended to whittle down the number of patents and initiate resolution of any disputes during FDA review of the aBLA. However, despite its high-minded objectives, litigation under the BPCIA has proven less harmonious than planned.
Developing Future Delivery Models For ATMPs: Practical Considerations
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.
PHARMA OUTSOURCING WHITE PAPERS
Hydrophobic Interaction Chromatography Resins For Next-Gen Challenges
To solve downstream separation and purification challenges for many biotherapeutic modalities, a suite of hydrophobic chromatography resins has been developed to cover a wide range of hydrophobicity.
The Use Of Cell-Free Synthesis In The Future Of Modern Medicine
Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.
Precision Powder In Capsule Micro Dosing Accelerates Drug Product Development
Advancing active pharmaceutical ingredients (APIs) through the drug product-development lifecycle is fraught with challenges. Development timelines are tight, so it’s crucial to determine early in the process if an API is a viable candidate for clinical testing. A key tool that has emerged to address these combined issues of tight timelines and complex molecules is precision powder micro-dosing in capsules. This paper describes the use of precision micro-dosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.
Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy
Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy.
Viral Clearance: The Basics On How To Conduct Effective Studies
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Extrusion- Spheronization, Engineered For Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of both today’s and tomorrow’s complex OSD therapeutics.
COVID-19 AND YOUR SUPPLY CHAINS
The Latest Analysis And Advice From Outsourced Pharma